Dxc 500i Clinical Analyzer
- Recalling firm
- Beckman Coulter NZ Ltd
- Product
- DxC 500i Clinical Analyzer. [Device]. Model: With ISE DxC 500 AU Module w/ISE, DxC 500i and Without ISE DxC 500 AU Module, DxC 500i. Affected: Software - 1.3.5 or earlier
- Reason
- The manufacturer has identified a software issue affecting DxC 500i Clinical Analyzer when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyser to revert the test units to the system default setting without notifying the user., The system does not provide a warning or notification to alert the user that the configured units have reverted to the default units.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-02
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a4838bfa-3ab3-4efe-97a3-2e10f5e0ac3b